Prostate cancer (PCs) represents about 30% of all cancers in men. For more than twenty years the wide use of biologic markers and screening campaigns have contributed to detection of the disease (PCs) at early stages, hence, aiming to improving the cure rates. This goal could be reached either by surgical removal of the gland (radical prostatectomy), radiation therapy or focused ultrasounds. Nonetheless, incontinence rates after these therapies are far from anecdotal. The literature reports an incidence of 5 to 45% of incontinence after radical prostatectomy and up to 7% of cases after external beam radiation therapy (EBRT). Furthermore, the surgery for benign adenoma such as transurethral resection or open enucleation also carries a certain risk of incontinence (about 1.9% of incidence).
Male stress urinary incontinence (SUI) that occurs as a result of sphincter dysfunction after radical prostatectomy is a devastating adverse event for patients and a frustrating problem for urologists. The incidence of this clinical condition ranges between 3% and 45%. Initial management is usually conservative and includes the use of diapers or pads, penile clamps, or various collecting systems (e.g. condom catheter). Mild degrees of SUI in the early postoperative period may be improved by pelvic muscles exercises, physiotherapy, and pharmacotherapy.
When these therapies fail to alleviate SUI, patients are usually offered one of the following surgical alternatives: bulking agent infections, artificial urinary sphincter (AUS) placement or sling insertion. Urethral or bladder neck balloon compression devices have also been reported by a few groups. Transurethral injections of various bulking materials have been used for decades and are minimally invasive, safe and well tolerated. Nevertheless, effectiveness is usually temporary, requiring multiple injections, and long-term results have been disappointing so far, with cure rates achieving only 20-40%.
Pioneered by Foley 50 years ago and largely developed by Scott in the early 1970s, the AUS has culminated in the hydraulic AMS-800 final version commercialized by American Medical Systems. Currently, the AUS remains the current gold standard of treatment for post-prostatectomy incontinence. Numerous reports with medium- to long-term followup of this procedure exist in the literature, with 61% to 96% success rates as defined by variable criteria. The results are generally lower among patients with radiation-induced or -associated incontinence.
Despite its attractiveness, the AUS is an expensive mechanical device that can fail and requires manual opening to empty the bladder and therefore dexterity and/or mental capacity to use the device. In addition, surgical revision or replacement may be required due to mechanical failure, infection or cuff erosion. The 5-year reoperation rate has been reported to range between 17% to 57%.
Sling procedures are conceptually attractive in that they are inexpensive, nonmechanical and allow for physiological voiding without significant obstruction. The use of fixed urethral compression for the treatment of male SUI began in 1961 with Berry who utilized acrylic prostheses to compress the ventral urethra against the urogenital diaphragm and was followed by the different sling procedures developed by Kaufman in the 1970s. Since then, various techniques of bulbar urethra compression using synthetic and/or biologic materials have emerged.
Sling devices are usually secured either over the rectus abdominalis fascia/muscles after retropubic passage, or at each inferior pubic ramus with the use of bone screws in order to avoid a separate suprapubic incision. Results from clinical series assessing the intermediate- and long-term outcome of sling procedures indicate that success rates may compare favorably with those obtained after AUS placement. Yet, no randomized study comparing the results of both procedures are currently available.
Even though in the majority of cases urine leakage will disappear within the year, about 10% of patients (from 5 to 45% in the literature) will require permanent pad wearing or any other protection system after this time span. Thus, a number of devices have been invented to reduce the social impact of incontinence. Besides the external systems (penile clamp, collecting bags, incontinence pads, etc.) surgically implanted materials have also emerged.
Periurethral injections have been developed for decades. Different materials have been used: collagen, Macroplastique®, autologous fat, Deflux®, but results are disappointing. And cure rates roughly reach 40%. Surgical urethral compression has been used since 1961, at first with acrylic prostheses designed by BERRY. Later, in 1968 KAUFFMAN invented an inflatable silicone prosthesis with polytetrafluoethylene fasteners.
Since then, different techniques of bulbar compression have emerged. Materials used are synthetic, biologic or both. A variety of anchorage systems are utilized: from retropubic passage with fixation to rectus abdominis muscles to bone anchorage to ischio pubic branches or passage into the obturator foramens. Some authors suggest peroperative multi-channels urodynamic studies to improve the results.